BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 16872390 · Received May 4, 2023

    Report

    Report Number
    9611451-2023-00381
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Report Date
    April 7, 2023
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K122432. FISHER & PAYKEL HEALTHCARE (F&P) IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K122432. METHOD: THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION AND PHOTOGRAPHY PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF OUR PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE COLLAR OF THE EXPIRATORY TUBING OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS CRACKED. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. ALL 950A81 ADULT VENTILATOR DUAL HEATED BREATHING CIRCUITS ARE 100% LEAK TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT 950A81 BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950A81 ADULT VENTED DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. SINGLE USE. DO NOT REUSE THIS PRODUCT. REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES, INTERRUPTION TO TREATMENT, SERIOUS HARM, OR DEATH. DO NOT CRUSH, STRETCH, OR MILK THE TUBING. DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE COLLAR OF THE EXPIRATORY TUBING OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS CRACKED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE COLLAR OF THE EXPIRATORY TUBING OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS CRACKED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486722 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD 950A81 2102222819

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown